NCT03531008

Human Epilepsy Project 2: Resistant Focal Seizures Study

Biomarkers, Health Outcomes and Healthcare Utilization in People With Resistant Focal Epilepsy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 157 (actual)
• Sponsor: Epilepsy Foundation of America · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The HEP2 study is designed to better understand the challenges of living with focal seizures that do not respond to medication, by following 205 people with medication-resistant focal epilepsy over two years to measure changes in health status, healthcare costs, quality of life, and biomarkers of epilepsy severity and treatment response.

Detailed description

The Epilepsy Foundation is launching a partnership, called the Human Epilepsy Project, in collaboration with the Epilepsy Study Consortium. This study (which is called HEP2 for short) is designed to better understand the challenges of living with focal seizures that do not respond to medication. The HEP2 study will follow 200 people with medication-resistant focal epilepsy (with seizures that occur at least 2 times per month) over two years to measure changes in their seizure frequency, treatments used, adverse events experienced, presence of co-morbidities like depression and anxiety, healthcare costs, and quality of life. Blood samples will also be collected in order to look for biomarkers of epilepsy severity and treatment response. Participants can join the HEP2 study at any one of nine recruiting study centers. These study centers were selected because they are epilepsy centers with track records of conducting high-quality research in epilepsy and efficiently recruiting participants into studies. The designated sites for the HEP2 study are located in New York, California, Minnesota, Connecticut, Pennsylvania, and Tennessee. A participant may enroll in the HEP2 study but continue to receive their standard epilepsy care with their current physician, as long as the participant is willing to share his or her medical records, and travel to the study center for two or three in person visits at the beginning of the study, after the first year, and a final visit after the second year.

Conditions

• Epilepsy
• Brain Diseases
• Central Nervous System Diseases
• Nervous System Diseases
• Biomarkers

Timeline

• Start date: 2018-05-07
• Primary completion: 2022-07-30
• Completion: 2022-09-30
• First posted: 2018-05-21
• Last updated: 2023-09-18

Locations

10 sites across 1 country: United States